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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K132365
Device Name SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
Applicant
Accel Spine
14901 Quorum Dr. Suite 125
Dallas,  TX  75254
Applicant Contact AEKTA PATEL
Correspondent
Accel Spine
14901 Quorum Dr. Suite 125
Dallas,  TX  75254
Correspondent Contact AEKTA PATEL
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received07/30/2013
Decision Date 08/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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